MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION IMAGER II ANGIOGRAPHIC CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	38270
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that a shaft tear occurred.An imager ii angiographic catheter was selected for use during a vascular embolization procedure.An interlock 35 coil was advanced through the catheter and could not be pushed past the middle part of the catheter.The devices were removed and it was observed that the imager ii angiographic catheter was torn preventing the advancement of the coil through the catheter.The procedure was completed with another same device and there were no patient complications.
Event or Problem Description
It was reported that a shaft tear occurred.An imager ii angiographic catheter was selected for use during a vascular embolization procedure.An interlock 35 coil was advanced through the catheter and could not be pushed past the middle part of the catheter.The devices were removed and it was observed that the imager ii angiographic catheter was torn preventing the advancement of the coil through the catheter.The procedure was completed with another same device and there were no patient complications.
Additional Manufacturer Narrative
(b)(6).Device evaluated by manufacturer; returned product consisted of an imager diagnostic catheter.The device was inspected for any damage.It was noticed that the device showed a perforation on the crown of the tip located 8mm from the tip.A.035 interlock test wire was introduced into the device and the wire transcended through the lumen and came out of the perforation that was notice.Inspection of the remainder of the device, apart from the observed damage on the box, revealed no other damage or irregularities.

• Brand Name: IMAGER II ANGIOGRAPHIC CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9447117
• Report Number: 2134265-2019-15416
• Device Sequence Number: 19356234
• Product Code: DQO
• UDI-Device Identifier: 08714729355489
• UDI-Public: 08714729355489
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: 38270
• Device Catalogue Number: 38270
• Device Lot Number: 0000128001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Initial Date Received by Manufacturer: 11/28/2019
• Supplement Date Received by Manufacturer: 12/20/2019
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 01/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INTERLOCK 35 COIL; INTERLOCK 35 COIL